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Some will blame current economic pressure on a subprime market that was more enthusiastic than realistic. Housing starts are down with consumer confidence following suit. A

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

ccording to The Conference Board its “March [2007] consumer confidence index fell to 107.2, the lowest level since November and a decline that was larger than Wall Street e

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

Examples of combination products may in

xpected.”

The good news is the Dow has performed well in the midst of this news while labor statistics remain strong.

Federal Reserve Chairman Ben Bernanke's testimony be

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

fore Congress on March 28th, 2007 found him concerned about the impact of defaults on subprime loans. Bernanke indicated that, “Although the turmoil in the subprime mortgag

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

e market has created severe financial problems for many individuals and families, the implications of these developments for the housing market as a whole are less clear. T

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

Combination pro

e ongoing tightening of lending standards, although an appropriate market response, will reduce somewhat the effective demand for housing, and foreclosed properties will ad

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

d to the inventories of unsold homes.”

Interestingly, news of the ‘bubble pop’ in subprime lending is rippling around the world. The European Union as well as Australia ha

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

ve been monitoring this leading economic indicator.

Chairman Bernanke indicated subprime loans account for about 10% of all mortgages. If banks have lost their ability to

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

derive a profit from these loans it may signal a slow down in this sector of lending adding additional pressure to housing starts along with the potential for loan default.

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

This news adds pressure to what had appeared to be a relatively stable economy.

The impact of a slow down in housing starts may have ramifications for business. Michael A

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

len is the CEO and founder of Allen Associates Executive Search. Allen said, "I receive about four or five calls a week from CEO's worried about plummeting housing starts.

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

Following aspects would a

We believe that North American building products manufactures have built infrastructures to support 2.3 -2.4 million starts. Based on the probability of 1.5 million starts,

dd to the challenges in developing combination products:

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

many of our clients will need to rationalize capacity by closing plants." Allen Associates is a leading executive search firm specializing in CEO search assignments for ma

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

jor building products producers in North America.

Certainly there may be regional pockets where housing starts are still strong. However, the general decline often has a n

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

egative overall impact on the economy due to the fact that housing starts can signal economic growth or, in this case, a slowing in the economy.

Many economic analysts bel

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

eve America is entering a period of sustainable economic growth. Essentially this means American business is likely to continue experiencing moderate growth, but as the rap

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

Professional from academic institutions, pharmaceutical industries, health care indust

id rate of home starts has declined so has the overall rate of growth.

American business will likely be forced to develop and implement new strategies based on this revise

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

d economic climate. This may include reduced output, a smaller workforce and the further streamlining of their operations. If the analysis from Michael Allen is correct we

.

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

could see, “…dramatic operational changes by June or July.”

The impact of a declined in housing starts does not necessarily indicate economic doom, but it is an indicator

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

Companies that provide selfless information through particip

that the economy is either struggling of self-adjusting. In either case American business interests will be forced to take corrective action on behalf of their shareholders

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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