Advice You - Business

Employers are gearing up for the coming generational change-out…the departure of the Baby Boomers from their work places and the continuing arrival of members of what

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

has become known as Generation Y. Whether employers realize the importance of this transition may well determine how successful the business will be when the change

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

Examples of combination products may in

over is complete a decade or so from now.

For the record, the Boomers first bloomed in 1947, meaning they begin to hit 65 in 2012. That is a scant five years from n

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

ow. And although many Boomers may elect to stay in the work force beyond the traditional 65-year-old retirement point, some will elect to enter retirement earlier, s

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

the transition may begin sooner than employers think.

In their final years in the work force Boomers will have an awesome role to play: nurturing, coaching and ment

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

Combination pro

oring the incoming generation of workers. The good news is that it can be a rewarding experience for all involved.

From the older employees’ perspective, younger wo

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

rkers are often characterized as computer-obsessed and “wet behind the ears.” In reality, the new worker is a pretty bright breed. The internet has been their frie

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

d all of their lives and global learning is old hat to them. Their baseline education level is higher than a Boomer could have ever hoped to have achieved this early

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

in a career.

The best part, however, is that the new generation of worker is eager for feedback… welcomes it and listens to it. It’s a generation accustomed to con

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

stant feedback from its computer-driven lifestyle and it’s a generation unafraid to try something new to produce better results.

It doesn’t, however, know the ropes…

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

he processes in a particular organization that have evolved over decades to establish “how we do things around here.” That’s where the older workers become so valuab

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

Following aspects would a

le to the new folks: helping them stay between the lines as they accelerate up to speed, and listening to the new workers when they question why the lines are drawn w

dd to the challenges in developing combination products:

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

here they are. A great mentor will explain the rationale behind the process when it’s explainable, and will join the new employee in questioning the process when the

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

mentor discovers it isn’t explainable. Sometimes a fresh set of eyes improves “how we do things around here!”

The boomer-coach will also allow the younger employee

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

he room to make mistakes, because Generation Y uses mistakes as learning experiences….they learn faster and more effectively “what works.” Remember it is okay for th

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

em to strike out a couple times if it’s apparent they are learning how to “read” the pitcher. It is not okay, however, to let them go to bat without a helmet. In ot

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

Professional from academic institutions, pharmaceutical industries, health care indust

her words, give them room but not enough freedom to create a catastrophe…for the company or for the employee.

The best practice a supervisor can follow is to maintai

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

daily contact with the new worker. Make it a point to chat with him or her every day; in fact, don’t make it a point, make it a priority. They will welcome the int

.

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

erest, pick your brain and quickly become a valuable part of your organization.

And when that day comes when the boss hands you the watch and wishes you well on your

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

Companies that provide selfless information through particip

retirement, you can look at the successful team you are leaving and say to yourself, “I built it.”

It’s a great way to leave the stadium.

(c) 2007, Workforce Chang

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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Advice You - The Care and Feeding of Generation Y

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