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General Motors Corp. announced in late November 2005 that it will close 9 of its United States auto manufacturing plants as well as three assembly-related plants which includes one location in Canada. Ford Motor Co. followed suit in early December 2005 announcing it is considering the shutdown of up to

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

8 of its U.S. manufacturing plants, including engine and assembly operations, with one in Mexico. Americans are well familiar with the downsizing, outsourcing and offshoring of the U.S. manufacturing base which has seen 2/3 of its jobs lost in the past 20 years, having been traded in for third world c

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

Examples of combination products may in

heap labor. And while white-collar workers have hardly been immune from offshoring practices infiltrating boardrooms, indication this week is that the tide has changed.

Both the Intel Corp., the world’s largest computer chip manufacturer, as well as J.P. Morgan Chase & Co., one of the world’s largest

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

financial institutions and 2nd largest in the U.S., are investing in creating new jobs in India over the next few years rather than in the U.S. Different in prior offshoring scenarios, however, is that back-office jobs such as investment banking, software engineering and research and development, previ

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

ously occupied by American workers, will now originate from India as well.

J.P. Morgan plans to locate 1/3 of its investment banking and support staff in Bangalore, India by the end of 2007. It will double the amount of its employees by hiring 4,500 graduates over the next two years. 3,000 of the new

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

Combination pro

hires will work in investment banking with 1,500 providing support in its retail and commercial banking operations. There are presently 4,500 employees in front-office staff positions in Mumbai, India.

With only 200 on staff in India just two years ago, in order to achieve their latest goal, J.P. Morg

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

an will hire between 300-400 graduates a month in order to have 9,000 total positions in front and back-office positions by 2008, which includes complex derivatives settlements and structured finance transactions. The remaining approximately 4,000 – 4,500 employees J.P. Morgan employs will be divided b

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

tween Bournemouth, England and New York, NY, although the ratio between both countries was not disclosed.

Similarly, Intel will invest $1.1 billion in India over the next 5 years, with $800 million dedicated specifically for research and development operations and other projects including chip design,

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

also in Bangalore, according to Chairman Craig Barrett. Although Intel will also explore expanding its manufacturing prospects in India, its present investment will largely be for more complex high-value work as opposed to just technical support and call-center jobs, which most IT firms offshore today

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

.

Other firms following this latest trend are Cisco Systems, the world’s largest maker of internet equipment, which announced in October 2005 that it would invest $1.1 billion in India, tripling its work force to more than 4,000 from 1,400 in the next three years. It too will have research and develop

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

ment located in Bangalore. And it is likely that more of the banking industry will soon follow J.P. Morgan’s lead such as Goldman Sachs & Co. which may double its staff to 1,500 in Bangalore.

Microsoft Chairman Bill Gates is expected to invest $400 million in Hyderabad, India where he plans to hire se

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

Following aspects would a

veral hundred workers. Gates has been outspoken, with his statement in April 2005, citing that there were not enough U.S. college students majoring in computer science, and thus wants to expand the H1B Visa program, allowing more foreign workers to come to the U.S. But critics believe that Gates and ot

dd to the challenges in developing combination products:

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

her industry executives are not being honest in their assessments, to wit, the banking industry’s India strategy which is hiring finance graduates and not computer science graduates in expanse of their industry.

In fact, consultants such as Stefan Spohr of AT Kearney estimate that investment banks cou

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

ld raise their staff levels in India to as much as 20% in the next few years. Since salaries in India are 70-80% lower than in the U.S., with total costs about 40% lower than in the U.S., the trend of offshoring will no longer exist. Rather, jobs will now originate from India and totally bypass the U.S

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

Disputing the fact that there are not enough quality candidates, for example, in the computing engineering field, is the change in the way in which U.S. engineers are hired. Candidates are not only competing with their peers but also with the fear that they will be replaced by either imported foreign

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

workers or offshore workers, even after they are hired.

Companies are directly contributing to the supposed engineering shortage themselves by requiring that an applicant meet every item on a detailed list of qualifications. Transfer of like-skills is a long lost concept. With approximately 200 respo

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

Professional from academic institutions, pharmaceutical industries, health care indust

nses for every job listing, companies have the luxury to hold out until they get the perfect candidate, as job cuts in technology positions are up 20% in the past year, according to Challenger, Challenger, Gray & Christmas. The unemployment rate for computer programmers and engineers is higher than the

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

national average which does not reflect those who remain unemployed in Silicon Valley as they no longer register for unemployment benefits, nor those who were forced to move on to other careers.

According to Veronique Weill, head of operations at J.P. Morgan’s investment banking division, “The qualit

.

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

y of the people we hire is extraordinary and their level of loyalty to the company unbeatable,” when referring to the hiring of employees in India. Funny, but that’s what used to be said about American workers. Perhaps the American worker’s biggest error was requiring a decent wage for quality work don

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

Companies that provide selfless information through particip

e. And others would argue that maybe it was their expecting U.S. companies would prefer them over foreign labor. Tragically, greed, under the guise of a global economy was the error, committed not by U.S. workers but by U.S. CEO’s, and condoned by the U.S. government.

Copyright (c) 2005 Diane M. Grass

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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