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Help wanted: professional, flexible, dynamic, well-organized, accurate, self-starter, independent thinker, upbeat, energetic, multi-tasked, experienced team player.

A lot to ask of any individu

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

al, especially one who has not played on any team since softball in the third grade!

Many businesses request a team player without knowing what that actually means. Being on a team means being i

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

Examples of combination products may in

ter- dependent in a relationship, being able to trust others.

First, one must be independent. If you cannot function well on your own, an office team can turn into an outlet for all your pers

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

nality flaws. An independent person knows what makes him or her tick, what’s important in their lives.

These values can then be brought to any team and become part of the contributing process.

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

People who can’t be managed or trust others will have a hard time being effective on any team. A team needs a reason to get together; a project or specific plan that requires results. The Team

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

Combination pro

lso requires that the owner/manager/supervisor is willing to support the team’s success.

Teams are not magic bullets, so here are a few suggestions.

How do you put a team together?

The owner/

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

anager of the business must be aware of how teams work. The team is accountable to each other, not the owner. The owner chooses the team leader. Teams require guidelines and need values of its

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

wn. Commitment, contribution, communication and cooperation are the four values or cornerstones of the foundation of any capable team or business.

1. Commitment. If one is not committed to the

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

lan and the team, nothing will work. Until there is commitment there is nothing. Being committed means being charged with a responsibility for a particular result. In this time of quicker and fa

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

ter, not many take the time to do whatever it takes to get the job done.

What being on a team truly implies is giving up your ideals for something greater than yourself.

2. Contribution. Diffe

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

ences are what make a team exciting. Not everyone on the team needs to be alike. I look at a team as a microcosm of the world. The team is your community if you were sliced off the end of the

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

Following aspects would a

earth. You must trust and be accountable to each other, not the owner.

The owner or manager may lead the team, but allows the individuals on the team to blossom and grow. No throwing cold water

dd to the challenges in developing combination products:

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

ver anything new or different! Teams can be about change and that is their greatest strength. Various people on teams bring an abundance of creativity - a total windfall!

3. Communication. At t

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

e beginning of any meeting, everyone should be heard briefly, without interruption. This is an opportunity to settle in, to connect before the real work starts. Continue the process with ever

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

one offering information about them, including that sense of humor sometimes missing in the workplace. Teams can be enjoyable and fun, but no one will know that unless team members relax and l

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

ghten up.

4. Cooperation. Pool all the resources and ideas of each individual while putting aside personal goals for the objective of the team. The significance of cooperation is to work toge

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

Professional from academic institutions, pharmaceutical industries, health care indust

her in relationship and that requires patience. A reminder: everyone on the team is an equal, without a boss.

A word of caution. Not everyone is a team player. People who are loners need just th

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

t, to work alone. As long as they can create results on their own, let them. People on a team have to want to be there. No one wants a person on a team that does not want to be there; they just

.

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

stall any progress.

Set your plan in motion and have fun!

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

Companies that provide selfless information through particip

notify me of publication by sending either a website link or a copy of your ezine upon publication via email at: joanne@joannevictoria.com.
~~~~

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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