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For the first time in many years the personal bankruptcy rate fell in Toronto in 2006, by 0.5%.

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

In fact, the personal bankruptcy rate was actually down in all of Canada in 2006, by an amazing 4.3%! The decli

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

Examples of combination products may in

ning rate of personal bankruptcy in Toronto was caused in part by a very strong employment picture. The unemploy

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

ment rate declined for the third straight year in Toronto to 6.6% (it was 7.7% as recently as 2003).

As a perso

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

nal bankruptcy trustee who meets with hundreds of people in financial trouble every year, I know from experience

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

Combination pro

that these positive statistics only tell part of the story. The other part of the story is that residents of Tor

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

onto, and throughout Canada, are carrying record levels of debt. Household debt continues to rise, up 9.8% in th

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

e first 10 months of 2006, and in September 2006 the ratio of debt to personal disposable income reached a recor

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

d 122%. This means that for every $4 the average Canadian earns in a year, they now have $5 in debt.

Some exper

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

ts believe that high levels of debt are not a problem. They say that because interest rates and the unemployment

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

rate are low, everyone can afford to service this debt. That's partially true, but my research indicates that a

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

Following aspects would a

small segment of the population is very vulnerable to even the slightest financial shock.

As a personal bankrup

dd to the challenges in developing combination products:

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

tcy trustee with offices in Toronto, I meet with people every day for whom rising debt levels mean they are one

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

or two missed paycheques away from financial disaster. A recent Bank of Canada survey found that the proportion

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

of highly vulnerable debtors (those whose debt payments exceed 40% of gross household income) has risen by 23% i

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

the first six months of 2006 (from 2.6% to 3.2% of the population). If any of those people lose their job, get

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

Professional from academic institutions, pharmaceutical industries, health care indust

sick, or get divorced, they may have no choice but to file bankruptcy to deal with their debts.

What's the solu

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

tion? I believe that we should all examine the level of debt we are carrying, and take steps to reduce it before

.

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

it becomes unmanageable. For many elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

">personal bankruptcy in Toronto may be the only option, but with careful planning bankruptcy can be avoided

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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At the leadership level, the success of a business intelligence endeavor often depends on the ability to 'see the whole picture'. In case of a Customer Intelligence project, combined skills of the project leader, on the identification of the appropriate marketing strategy and the implementation of the latter based on a successful design & implementation, allow him to identify issues early-on and steer the project successfully.

Your old car just went to pieces today and you have very little money in your pockets. You could go to the bank for a loan and beg the loan officer to give you some cash at a sky high interest rate. Perhaps you could look at the very limited selection at one of those local car dealerships that offer financing on a high sticker price made even higher by the interest rates they plan on charging you. You could do either of these things but you wish there was another option. Well, there is and it's called Ebay car auctions.

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