The Life Sciences in New York State

links for 2005-07-31

• Biotech outsourcing in India picks up pace
  IT outsourcing, not formulation work, as the article suggets
  (tags: outsourcing pharmaceuticals India)
• Senator Frist's Stem Cell Shift
  (tags: stem cells)
• Who Knew a $10 Bill Had Such a Nice Bouquet? - New York Times

del.icio.us working again

I am now able to once again use del.icio.us. I have no idea what went wrong, nor did I do anything to fix it (although I'll claim that I did!). I consider del.icio.us to be an important extension of my blog, so I'm glad it's working again.

Skype for Sale - Rumor

Rumors are resurfacing. This time, Rupert Murdoch offered $3 billion for Skype.

Original article is here.

Perspective from Skype Journal is here. They asked the same question I did, which is "How do you value Skype?"

Last we heard, Yahoo! wanted to buy Skype.

It's only a matter of time before someone gobbles them up. Let's start a new rumor...

Google is in serious merger discussions with Skype. The new company, to be called GooSky....

I can't log into my del.icio.us page

Anyone else having problems? I'm getting an "Operation timed out when attempting to contact del.icio.us" message....

Not a good sign...

It's never a good sign for a company executive when he announces that he's leaving, and the market reacts positively:

Schrempp's leaving added some 3.7 billion euros to the firm's market value. The stock has underperformed sector peers by half since Daimler-Benz's 1998 merger with Chrysler, which Schrempp trumpeted as creating the first truly global carmaker.

"This is the day I've been waiting for," said JP Morgan automobiles analyst Philippe Houchois. "It's a wonderful day for the auto industry as a whole."

NY #2 in biotech

Link to press release. Link to original article.

Quote:

The Business Review (Albany) - 3:03 PM EDT Tuesday

                         

Magazine ranks New York No. 2 for biotechnology

                                      

Richard A. D'Errico

The Business Review

                    

            

Gov. George Pataki touted the July issue of Business Facilities Magazine, which ranked New York No. 2 in the nation for developing biotechnology.

Business Facilities is a magazine for companies seeking to expand or relocate their companies.

"The State's high ranking in this important industry magazine is yet another sign that our unprecedented efforts to promote high-tech, biotech and small tech research and economic development is returning major dividends," Pataki said. "The high technology we're creating today is helping to create the new jobs and economic growth of the future all across New York state."

The news came the same day members of the media toured a new $45 million biotech facility in the state University at Albany's East Campus site in East Greenbush, N.Y. The building is expected to open next month.

Business Facilities measured eight factors in determining its rankings, including the number of establishments in four major biotech sub-sectors agricultural feedstocks and chemicals, drugs and pharmaceuticals, medical devices and equipment, and research and testing.

Last year, New York's colleges, universities, medical research centers, and biotechnology companies were awarded a record $1.96 billion in funding in federal biotechnology research grants, beating the previous record of $1.89 billion set in 2003.

New York state leads the nation in top 100 medical institutions receiving federal life science funding, Pataki said.

 

[email protected] | 518-6807

© 2005 American City Business Journals Inc.

Comments on Microdosing

One topic which I have been keenly interested in is microdosing. What is it?

Simply stated, microdosing is a technique whereby experimental compounds are administered to humans in very small doses (typically 1/100th of a therapeutic dose). The drug's pharmacokinetics are characterized through the use of very sensitive detection techniques.

Why is this interesting? Prior to microdosing approaches, pharmacokinetic characterizations were always performed in animals (typically rats, but dogs and sometimes monkeys may be used). Other techniques may be used (e.g., liver microsomes) to supplement these data. The bottom line is that even with all of these data, candidates may still fail in Phase I clinical trials due to pharmacokinetic issues such as poor oral absorption.

Microdosing enables companies to characterize directly human pharmacokinetics. This enables companies to reduce their dependence on animal data which can be misleading. Plus, you are looking at "real" human data. Via microdosing, you have an excellent estimate of bioavailability, half life, clearance, etc., etc. Now there are many instances where pharmacokinetic characteristics are dose dependent. But, even in those cases, microdosing gets you much closer to an intelligent go/no decision versus purely animal and in vitro studies.

A few good introductions to this approach are here, here, here, and here. 

The US FDA has recently issued guidelines on the use of microdosing techniques, and major pharmaceutical companies are all over this already. I'm curious to see if the major CROs are offering this as a service.

Is drug development as slow as we think?

Many of us in the industry have noted the slowdown in product introductions by the pharmaceutical industry. The statistics bear this out. In 1996, there were over 50 new chemical entity approvals by the US FDA. Since then, the number of approvals per year has declined steadily to around 20 in 2002, with a climb back into the 30s in 2004. Analysts and pundits have blamed the blockbuster mentality, inefficient R&D processes, and a realization that we sometimes simply don't have a clue as to what is happening in a complex biological system.

Or, is it all as bad as we think? The August 1 issue of Drug Discovery Today (subscription required; individual articles available for purchase here) has a fascinating analysis on the subject. The authors (2 senior scientists from Pfizer) decided to analyze the approvals from 1939 to 2003, arguing that a much longer time frame is required because the development and approval process can take such a long time.

Note to VCs: Approval may take a long time, but exits may be much shorter. But, I digress...

The authors make two very interesting observations:

1. They note that approvals are cyclical over the long term, and upward trends are driven partially by changes in regulation. For instance, the 1992 FDA reforms (PDUFA) enabled the FDA to bring in more staff and process applications faster, resulting in the peak of 1996. Conversely, increasing interest by the FDA in cardiotoxicity in 1998 drove the slowdown in approvals. I'll buy the PDUFA stimulus argument, but I'm not entirely convinced that interest in cardiotox alone drove a decline in approvals. However, it's an interesting notion.

2. If you look at approvals per decade, the most recent one (1995-2004) has been very productive, resulting in 307 approvals versus 220 during the decade of 1985-1994. No other decade has come close to the '95-'04 period. Similarly, drug launches in the last period (381) far exceeded any other decade (242 during the '55-'64 period). So, over a longer time horizon, the industry has had its most productive decade ever. This is in spite of the rapidly rising costs of performing R&D.

It's an interesting notion. What the article only begins to discuss is the Return on Investment for all this innovation. The authors are essentially saying that if the industry spends more, and if the FDA has the capacity to process approvals, then the industry can commercialize more and more products. However, the challenge remains for the industry to figure out how to hold spending steady while improving approval rates in a increasingly globally competitive industry. 

links for 2005-07-26

• Teva Pharmaceutical Industries to buy Ivax Corp. for US$7.4 billion
  (tags: pharmaceuticals generics M&A)
• American Bio Medica introduces new screening product
  (tags: NY companies diagnostics)

Where have you been?

Working! I've been in the middle of a few intense projects, hence no time to blog. If you see my delicious links on prior entires, you'll see a few of the things that I've spotted this week which are of interest. Maybe I'll comment on a few of them next week. But, the weather is beautiful here in the Hudson Valley, so I'm heading outside with the kids.