The Life Sciences in New York State

China overtakes India...or does it?

I'll take their word for it. But without seeing how this study was actually conducted, it's hard to make any definitive conclusions. For example, are they counting trials being outsourced into the country versus those for domestic approval and commercialization?

China overtakes India in drug testing

...China now has a cumulative total of 510 completed or ongoing trials compared with 471 in India, which had until recently been ahead on both measures. The trend reflects intensifying interest by the healthcare sector in China, which is growing rapidly as a result of rising income and expanding health coverage and is already forecast to be the world's fifth-largest pharmaceuticals market by 2010.

Smith and Nephew moving production from Florida to China

So they are buying land, building a new plant, and the economics still favor China. Interesting that they say that the production in the UK will be unaffected. OK, but for how long?

Smith & Nephew PLC move production from US to China

Smith & Nephew has purchased land in China and plans for the construction of a new plant are underway.

The Future of Work

The 20 August issue of Business Week has a series of articles on The Future of Work. On the surface, this may appear to be old news, that is, using the Internet, VOIP, IM, etc. to coordinate workers around the world. Any number of books have covered this topic. But this series of articles stresses the challenges embedded in this novel way of doing business. One of the key themes, in my view, is that coordinating global teams may lead to a loss in efficiency due to time zone differences, other (unknown) demands on worker time, etc.

Where I think these articles fall a bit short is that they are overwhelmingly focused on multinational companies such as IBM and Dow. Precious little space is devoted to entrepreneurs and small companies. Yet many of my clients struggle with these very issues, i.e., how to coordinate drug development teams in the US and India.

Regardless, I think these articles are worth a poolside read.

A Guide For Multinationals

For global corporations, the borderless world of Willy Chiu offers a glimpse of what's to come. International success once meant having bodies and factories on the ground from São Paulo to Silicon Valley to Shanghai. Coordinating their activities was a deliberately planned effort handled by headquarters.

The challenge now is to weld these vast, globally dispersed workforces into superfast, efficient organizations. Given the conflicting needs of multinational staff and the swiftly shifting nature of competition brought about by the Internet, that's an almost impossible task. And getting workers to collaborate instantly—not tomorrow or next week, but now—requires nothing less than a management revolution.

Shortages of qualified CRO professionals in India

I've been hearing various rumblings of this growing problem in India. What's concerning is that it's a broad array of capabilities that are being faced with shortages...data management specialists, clinical investigators, specialists in pharmacokinetics, etc. So it's MDs and PhDs and MS-level scientists, AND their supporting technicians.

I recently spoke with a toxicologist in The Netherlands who told me
that his CRO does work for Indian pharmaceutical companies. When I
asked him why, the response centered around their desire to enter
European markets. This answer didn't make a lot of sense to me, but I
didn't probe further.

This is a real problem. Is the Indian CRO market capacity constrained due to lack of personnel? Will CROs in India begin to outsource to other countries?


Clinical research sector faces shortage of 10,000 professionals

Clinical research sector in India is facing an acute shortage of technical people with the increasing flow of contract research jobs to the country. According to an industry estimate, this sector is in short of 10,000 professionals currently, and at the same time attrition rate has risen to 20 per cent.

AMRI continues expansion in India

Albany Molecular completes purchase of Indian manufacturing sites

The plants, in Aurangabad and Navi, were purchased from the Runwal Group, and also come with additional land for expansion. AMRI, an Albany, N.Y., drug discovery company, already has said it plans to invest $15 million over the next three years to expand and upgrade the Aurangabad facility.

Do you need access to CROs in India? I can help.

I will on occasion help my clients identify and develop relationships with contract research and services firms in India. It never occured to me until recently that many US-based companies really struggle with this.

In my experience, the keys to success are:

1. Ignore any preconceived (or ill conceived) notions about the quality of the work that will be done, the language issues, the time zone issues, etc. All the folks I've ever worked with in the Indian life sciences sector are very professional, highly skilled, highly educated, and keenly interested in growing their business by serving their clients (you) well.

2. Start small. Find one or two small projects and begin to develop a relationship with one or more CROs. Grow the relationship from there.

3. Don't let concerns about the loss of IP hinder you. It's a valid concern, but only if you choose to work with people that are not ethical. That's just as true here as it is there. Nobody wins when IP is stolen.

What's available? You name it:

>Discovery services
>Lead optimization
>Assay development
>Any Preclinical animal model you can think of
>Clinical data management
>Market research services

The list goes on and on.

If you need help, send me a note and I'll try to steer you in the right direction.

Aurangabad, we have a problem

There are those on the marketing side of the pharmaceutical industry who say that you are not really pushing the marketing envelope until you start receiving warnings from the FDA. From a manufacturing perspective, however, the last thing you want is a warning from the FDA...

WARNING LETTER CITES WOCKHARDT FOR CGMP VIOLATIONS

Documentation of environmental monitoring was also delayed for eight months, and when provided it consisted of an employee preparing a drawing from memory for the investigator, the letter said.

Australia Ranked #1 As The Best Place To Do Clinical Trials

Interesting that Australia is positioning itself as a low cost site for clinical trials...lower than India, of all places. Scroll down to the November 2005 portion of the page.

Australian market entry support available

I have developed a series of excellent contacts in Australia. If anyone needs Australian market entry advice, financing in Australia, or even Australian vacation and wine tips, please drop me a note.

Why China?

The CEO of San Jose-based Sage-N has a good answer to that question. I find the order interesting.

Drug Discovery News: Informatics

Why China? Simple, Chiang says: Market, talent and cost — in that order of importance.

He also notes (with my emphasis):

Chiang plans to roughly double the size of Sage-N with the expansion
into China, and expects staffing to be about evenly split between
Silicon Valley and Shanghai, at first. In the long run, though, Chiang
thinks having close to 80 percent of staff in China and around 20
percent in the United States—with a smattering of people in Europe—is
the best mix for the company.