The Life Sciences in New York State

CROs banding together

Interesting. Three CROs in China are banding together to provide a much broader suite of Discovery and Preclinical capabilities.

First CRO Service Alliance Formed in China

Sundia MediTech, United Pharma and HD Biosciences will be on the cutting edge of synthesizing new pharmaceuticals, lead optimization, molecular bio-assay development and tests, in vitro and in vivo PK/ADME research, and cGMP required intermediates and API for clinical trails...

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.

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.

Seeking book recommendation

Last year, I read Three Billion New Capitalists, an excellent treatment of the opportunities and challenges we're facing in a global environment. I recently started reading The World is Flat, which I think is an excellent primer on these issues.

So, I think Flat is the primer, and Three Billion is the in-depth analysis of the drivers of these challenges and opportunities. What I need is a book that looks forward and addresses how businesses (especially small businesses) can exploit these trends. It's very easy to say "outsource the grunt work to India," but actually executing is an entirely different matter. How does one select a vendor or partner? What are the risks, legal and otherwise? What are the implications, organizationally? Financially? Are there alternatives, such as the JetBlue "home sourcing" model described in Flat? What about other countries, e.g., Australia? What about Canada?

I don't think a book can answer these questions. Indeed, I don't think one should try. However, I think a good book that describes a framework to help business owners analyze these issues could be quite useful and valuable. 

Any suggestions?

Telecommuting

Short article on the growth, pros, and cons of telecommuting. I agree with the article that we're at the tip of the iceberg regarding telecommuting.

The Week Magazine

Looking for compounds...

I'm working with a group of investors who, in turn, is looking for drug candidates as investment opportunities. The investors would invest in the development of the candidate itself (not the company) in exchange for various risk/reward sharing arrangements. It's an interesting model, blending venture capital techniques with drug development processes.

If you work for a pharmaceutical or biotechnology company, and have compounds (lead or back up) which are languishing due to a lack of funding, please let me know. I may be able to make the connection. Compounds from academia would also be considered if the data package is robust enough.

Albany Molecular opens permanent lab in India

Today's announcement makes Albany Molecular's presence in Singapore and India permanent. Key phrase is:

"The move into our permanent home in Singapore, and the opening of our first laboratory in India mark two more milestones in Albany Molecular's history," said Thomas D'Ambra, chairman, president and CEO of Albany Molecular. "Our worldwide chemistry services platform has enhanced our ability to provide customers with a flexible range of services and competitive cost models."

How much do you suppose AMRI is saving by having projects run out of India?

Pharma companies going East

There's an entry today in Biopeer regarding the investments being made by multinational companies in India and China. There is no question in my mind that the continued fluid movement of capital meeting highly advanced resources can fundamentally change how drugs are discovered, developed, and marketed. I think there are four basic areas where pharma can move East:

1. Data Management - Includes storage and retrieval of raw data, interpretation of preclinical and clinical trial results, biostatistical analyses, etc.

2. Technology Sourcing - Areas of research (e.g., tuberculosis research in India) which may lead to new drug candidates.

3. Clinical Trials - Actual performance of clinical trials in India and China.

4. Commercial Infrastructure - As these economies continue to develop, they will become critical markets for approved drugs.

One possible trend emerging is the idea of start up biotech and pharma companies establishing corporate offices here in the US, but establishing strategic R&D relationships in India and China. IP/Patent and communications (really, management) issues aside, these types of companies can leverage their capital by enabling substantially larger numbers of people on projects, potentially accelerating development and quickening the time to exit for investors. It's an important model, and one which savvy investors should note.

Offshoring article - very confusing

Saturday's edition of The Times of India has a very confusing article on "outsourcing". It start's off this way:

WASHINGTON: India and China account for only 1.6 per cent of total employment of US multinationals by way of outsourcing, the government's figures have revealed, dispelling notions spread by critics of offshoring that the two countries are swallowing American jobs.

Latest figures released by the US Commerce Department show that by contrast, Canada was home to more than three times as many workers for US multinationals as China.

The UK was home to about nine times as many workers as India. Also, for each job in low- or mid-wage countries in 2003, US companies employed more than 10 workers at home.

The author of the report, Raymond Mataloni, said the numbers "don't provide a lot of support for the notion that massive offshoring is going on."

Now if I'm reading this correctly, they are confusing a US expat working in India (or China, or Canada, etc) versus an Indian (or Chinese, or Canadian) performing work in India which was shifted from a US site and performed by an American. Having an executive from Microsoft in Redmond transfer to Microsoft in China for a few years is not an "outsource".

Am I reading this incorrectly??