Useful Articles - Business

The past few weeks have presented nothing but bad news for the formerly world leading American automobile industry. Henry Ford must be rolling over in his tomb. Alfred Sloan, the architect of the multi-division Genera

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

l Motors juggernaut, is a very sad “car guy” in the sky these days. Plant closings, huge employee layoffs, lost market share and horrid fiscal performance indicate that the “big three” (including Daimler-Chrysler) are

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

Examples of combination products may in

in big trouble. They must change, and change is not pleasant for huge business complexes, or for employees, suppliers or customers.

This brings to mind a change that occurred right before my eyes as a small boy grow

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

ing up in Kentucky. Several times each week, a horse drawn ice wagon would pull up in front of our little house and deliver block ice. The iceman was named Herb. My mother would always pleasantly greet Herb and they w

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

ould exchange small talk, how about that the Reds game last night or the nice weather we were enjoying. Herb was a hard working and very nice man. And then, one day this regular ritual in our lives abruptly ended.

My

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

Combination pro

parents bought a refrigerator. The hand delivered block ice that was essential to keep the old icebox cool was no longer needed. My mother was very concerned about the effect our new wonder appliance would have on He

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

rb. She met him in the yard and told him as gently as possible that his ice deliveries were no longer needed. Then she asked him if he would like some iced tea and to sit a minute.

As clearly as I remember anything i

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

n my youth, I remember that conversation. Herb knew the inevitable march of progress and technology; in this case a 12 cubic foot Frigidaire, meant that he was soon to be looking for another line of work. It was sad.

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

He was very matter of fact and my mother tried to be encouraging. Over the next few months we saw Herb in the neighborhood less and less. Within six months the ice Company was out of business.

Accept Change or Get Ru

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

n Over

Like the barrel industry, the bicycle industry or dozens of other formerly thriving business segments, the ice delivery service, and now the American automobile industry was forced to change business models. I

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

change were not embraced, indeed aggressively pursued, industry subsets would be superceded by new upstarts and technologies. “The Big Three” still have an opportunity to adjust to new market realities, but they will

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

Following aspects would a

have to be relentless in the pursuit of economies, creativity and changing cumbersome bureaucratic business cultures.

Change is short-term pain. Managers will be significantly fewer. Blue-collar workers will not ear

dd to the challenges in developing combination products:

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

n $65,000 plus per year for unskilled labor in new jobs. Communities will undergo brisk changes in tax revenues, real estate prices and shopping patterns. College plans will be upset. Retirement dreams will be delayed

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

, in some cases destroyed. Parts suppliers will be pressed on pricing. And yet, the future for all effected parties can, and should, be bright.

Since the Luddites in the mid-19th century attempted to stop the industr

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

ial revolution and preserve old-world work models, there have been groups trying to thwart progress. Progress requires change. Fortunately, looking in the rear view mirror is not a widely admired American trait. The p

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

arties most effected by this sea change in the American auto business have multiple opportunities to re-train, re-strategize, and start new businesses and services. With normal American drive, work and creativity our

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

Professional from academic institutions, pharmaceutical industries, health care indust

society will be blessed with a new generation of wealth creation, entrepreneurs and growth. It has always been so.

We live in a global market place. Nothing will change that. If foreign auto companies make better pro

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

ducts at a better price we have to confront, and overcome, these market realities. Americans always have in the past, and there is no reason not to foresee a bright, but different future, for every current participant

.

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

involved in the radical restructuring of our formerly great auto business.

The American economy is the most dynamic in history. Opportunity abounds and is available to every citizen willing to compete in the marketp

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

Companies that provide selfless information through particip

lace of ideas, work hard and not look backwards. Ford, Chrysler and GM can survive and prosper. Nevertheless, understanding and preparing for change will separate the successful from the losers, or modern day Luddites

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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Without qualified vendor participation, your reverse auction will not be successful. Notice that I interjected “qualified” before vendor. There is absolutely a reason for that and I will cover two good reasons in article.

When young children misbehave, many parents, teachers and caregivers insist on a time-out. Think how much better your workplace would be if you initiated the same approach. No, not for your boss or coworkers, but for yourself.

With 250+ paralegal programs approved by the American Bar Association (ABA) and an estimated 1,000 colleges and universities, law schools and proprietary schools offering formal paralegal training programs - the field is highly represented.

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