Law under the Microscope

A Few Basic Tips to Increase Your Company's Information Security

When you mention "information security" nowadays to most company executives, their eyes glaze over either because they are expecting a stream of geek-speak to spew forth or because it causes them a massive headache to even think about. I've given a couple talks recently about what companies in various industries can do to help keep their information and trade secrets from being released into the general public (including a presentation at a conference by the American Conference Institute on Clinical Trials, held last month in NYC, and which will be held again in September in San Diego - check the American Conference site or email me for more details), and it's become really clear that many companies don't realize that they can probably stop 70% of attempts to retrieve confidential information by following  a couple very basic, very cheap tips.

So here are just a few tips that any company can implement and for which the cost will be pretty darn low:

Median VC Investment in Life Science Companies Jumps 30% in 2004

Some good news for Friday - industry researcher VentureOne has released data showing that the median valuation for a start-up life science company went up in 2004 from $10MM to $13MM (that value being the value of a company prior to receiving venture capital).

Venture One's explanation for this was more capital being available as well as a fairly finite number of "promising investment opportunities."  That's to be expected, though - as the investors get savvier about the industry and what really has a shot, they are going to narrow the field of potential ideas.

Will Tysabri Withdrawal Revive Call for Stronger Drug Safety?

Yesterday, I noted that Biogen and Elan had taken their joint blockbuster drug, Tysabri, which treats MS, off the market temporarily because 2 patients had developed progressive multifocal leukoencephalophathy (PML). Each of these patients were taking another drug, and one of them has died from the condition.

Tysabri had been approved under the FDA's "fast-track" approval system, and some articles are now saying that this recent series of events may bring about another bout of hysteria about drug safety and call the FDA's fast-track system into question (this last link is to a WSJ article and requires a subscription). I say "poppycock" to that.

Biogen and Elan Withdraw Blockbuster Drug Tysabri from Market

Last week, Biogen and Elan Pharmaceutical withdrew their joint blockbuster drug, Tysabri, from the market. Tysabri treats multiple sclerosis, and it had been widely awaited for release to the market by MS patients. Taking the drug off the market was not a wholly unreasonable decision as two patients who had taken Tysabri for over two years in clinical trials (in conjunction with another drug developed by Biogen) had developed progressive multifocal leukoencephalopathy (PML), one of whom has died. As may be expected, stock prices of both companies were effected by the announcement of the drug's withdrawal.

This goes beyond mere stock prices of sales, though, and gets into the issues of how do we determine which drugs are "safe," what is our definition of "safe," and the next generation of bioscience development.

Chiron Gets Ok for Liverpool Flu Vaccine Facility

Last fall, a storm of panic came about when Chiron's facility to make a flu vaccine in Liverpool, England was closed down because of contamination. This lead to a shortage of the vaccine, price gouging by some sellers, and even theft of the vaccine. Interestingly, I haven't yet heard of any epidemic of the flu nor of any deaths due to someone not receiving the vaccine.

Chiron announced today that the UK regulatory authority in charge of overseeing conditions in such facilities as lifted the suspension of work there, and Chiron will have the factory up and running. This is likely a relief for Chiron and for those concerned about getting the vaccine next winter.

The re-opening of the facility, while a welcome development, still does not address many of the issues that were highlighted when it was shut down.  The FDA has made some noise about coordinating more closely with the British agency so that there is more warning of these type of events, but a concrete plan to do so hasn't been implemented yet. I guess we'll add another line to Dr. Crawford's to do list.