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On any week day go to any coffee shop and you will find a relatively new and growing phenomenon. Men age forty and older sitting drinking coffee while working on laptops, talking on cell phones and reading business journals. Who are these men and why are they sitting in coffee shops?

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

THE SITUATION

The number of men who work for corporations and are over forty who have been either laid-off or forced into “early retirement” has grown every year over the past decade in spite of a robust economy. These men are mainly white and middle to upper middle class. They have

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

Examples of combination products may in

at least a college degree if not an advanced degree. They started their careers in a variety of capacities with large corporations but invariably they found themselves in white collar management positions at some level by the time they were age forty. By the 1990’s companies were fla

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

ttening their hierarchy to be more competitive in a global economy and reduce expenses to improve profitability. The people at the top rarely went. The people at the bottom were either needed or protected by unions or other conditions. The easiest targets were the white collar middle

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

managers. More work could be shifted to those below them. And if they needed to be replaced over time, younger workers could be promoted or hired to do the work at a much cost. At the same time, many companies began outsourcing “non-core” work functions to contractors who also were

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

Combination pro

selected for their low cost approach. And some functions were just eliminated as unnecessary.

The unspoken contract that these middle age white men believed in and worked for was broken when they needed a job and a paycheck the most. They had kids in college, mortgages and many had l

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

arge debts from chasing the middle class dream. They were told if they went to college, got a job with a “good business” and worked hard, they could count on a job until they retired. They also were told if they did a good job they would slowly advance up the many levels of the corpor

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

ate ladder. All of these implied promises proved to be false. And they proved to be false when, for many, it was too late to start over at a low paying entry-level position. Those making $75,000 to $125,000 per year in salary plus full benefits plus a pension were now left with no pa

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

ycheck, no benefits and a gutted pension with too little to retire “early” on.

While much can be said about their options, the more important question is what SHOULD be done to help this great and underutilized resource?

The answers are not always the typical ones: become a consultant

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

, become an entrepreneur or get retrained in a highly technical field. There are already too many consultants going after the same work. And big consulting firms dominate that field anyway. Many of these men went to work for large corporations for the very reason that they were NOT e

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

ntrepreneurs. Contrary to the current popular myth, not everyone is an entrepreneur. And finally, many of these men studied engineer or programming or accounting while in their youth. Many at age forty plus have no desire to learn the basics of a technical field and compete for those

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

Following aspects would a

entry level jobs with a twenty-two year old.

So what are the options left for these forty plus white men who have a life-time of business experience and no jobs?

SMALL BUSINESS

There are many existing businesses that make less than one million dollars a year. Most want to grow and

dd to the challenges in developing combination products:

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

be more successful. The functional and organizational skills that these men have developed over the years could be invaluable to helping small businesses succeed and grow. Many small business people have never worked for large businesses. As such they dismiss many of the good – along

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

with the bad – ideas that make corporations operate.

TEACHING

Teaching is another option. In this case I am not talking about walking in as an elementary or middle school general teacher. Rather, the skills in business and functional areas that these middle age former managers deve

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

loped over the years would be very valuable in a high school business, community college, junior college or professional – trade school environment. The key is to meet the skills and background with the need. And the need is great.

GOVERNMENT

We see in the media on a daily basis who

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

30-40% of those in government will retire over the next ten years. The professional and functional skills that these unemployed former managers have could be invaluable to the governments of towns and municipalities, counties, states and at the Federal level. Not to displace the peop

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

Professional from academic institutions, pharmaceutical industries, health care indust

le working today. And not in lieu of hiring the new college graduates. But to supplement the work force in roles requiring experience in engineering, accounting, management and administration to name only a few of the many areas of need.

MENTORING

Finally, these is the need for forma

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

l mentoring programs that take advantage of the resource that sits in the nation’s many coffee shops in lieu of a corporate office today. They have, without exception, years of experience in business plus many functional specialties. That experience should be tapped to mentor young pe

.

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

ople, struggling business people and non-profit organizations. There is a very real need to match the skills and the talent with the need in this area.

While there always have been and will be men sitting in coffee shops rather than offices, the number has grown to shocking levels. S

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

Companies that provide selfless information through particip

teps should and must be taken to identify and channel their skills, experience and motivation into the areas lacking in resource and ability today. Government, small businesses, education and mentoring programs would all benefit greatly from the infusion of their experience and skills.

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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We all have them. The membership directory or list. How can these be used to our advantage? Is sending a marketing piece the only way? Read more for another idea.

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