Main Subject - Business

For the year leading up to the turn of the century, IT resources were bound up making sure disaster did not hit when the clock struck midnight on that special nig

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

ht. Outsourcing was at its highest, for overseas firms who made a specialty of Y2K (year 2000) preparedness.

After the Y2K scare was over, there was a slight sl

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

Examples of combination products may in

ow-down in the need for talented technical professionals. A slight decrease in new outsourcing contracts followed. But the growing acceptance of the Internet as

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

a viable business outlet has fueled IT department growth once again. According to the Gartner Group, the investment in new information technologies projects wil

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

l double in the 2006 to 2010 time frame and those companies not recognizing IT as a key element to their business will fall behind their competition.

The Experto

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

Combination pro

Group has stated that in the next few years, outsourcing “would be the driving force behind IT market dynamics”. Recently American companies have decreased offsh

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

ore outsourcing, but European company outsourcing contracts are on the rise. This is contrary to previous predictions that outsourcing in the U.S. would increas

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 and IT jobs there would decrease. Neither prediction seems to have come to pass. In the first quarter of 2007 U.S. IT staffs have increased slightly.

Outsou

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

rcing is still very important in the U.S., not only for cost considerations, but also because sometimes specific skills are hard to come by and perhaps not worth

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

hiring for and administering in-house. In fact, cost is less of a factor, as it is slowly rising and may not pose much of a cost savings much longer.

Another wa

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

that outsourcing is changing in the United States is referred to as “multisourcing”. Far fewer companies are contracting mega-deals with a single vendor, as was

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

Following aspects would a

the previous strategy. These deals were set up to provide the company all its outsourcing needs in one place. Instead today’s companies are seeing the value in

dd to the challenges in developing combination products:

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

reducing project scope for offshore vendors. They are going back to hiring for specific projects from different vendors. A good process for organizing contacts

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

and projects, of course, must accompany this. Gartner predicted that now through 2009 the market share for the top 10 outsourcers will decrease from 43.5% to 40.

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

0%, largely because of this trend. That is a revenue shift of about $5.4 billion.

CIO Insight predicts that outsourcing destinations will shift away from India.

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

It’s interesting to note that Indian vendors are increasingly seeking mergers with Chinese and Eastern European firms. This lowers their overall costs and keeps

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

Professional from academic institutions, pharmaceutical industries, health care indust

India firms in the game. It also makes them more acceptable to European firms, who show a strong preference for outsourcing to vendors as near home as possible.

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

Morrison & Foerster’s Global Sourcing Group has highlighted another interesting trend, that of “transformational application outsourcing”. In this specialty, a

.

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

vendor firm is hired for their expertise in restructuring code into a modern architecture.

In general, outsourcing will continue to deal with issues of data priv

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

Companies that provide selfless information through particip

acy and security, as well as intellectual property rights. Outsourcing service providers will be expected more and more to drive innovation and deliver expertise

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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