Sunday, December 09, 2007
The First Billion- or Trillion-Dollar Organism?
According to a recent ETC Group press release, Synthetic Genomics founder Craig Venter is applying for some very broad and sweeping patents on a speculated first human-engineered species. The report cites a statement made by Venter to Newsweek: “If we made an organism that produced fuel, that could be the first billion- or trillion-dollar organism. We would definitely patent that whole process.”
The ETC Group report is available as a PDF and we also recommend looking over their explanations of the synthetic biology industry in comic form (the image above is from the "Syndustry" comic).
Wednesday, December 05, 2007
The Logic of Biotech Bets
I just read a business report about the corporate biotech moves in the realm of "biologic" drugs - drugs produced by living matter, rather than chemically derived in a lab. Or to put it more specifically: A biologic is a prophylactic, an in vivo diagnostic, or a therapeutic substance that can be made only by a living system and that has a large, complex, inherently heterogeneous molecular structure. Basically, the benefit of such drugs is their supposed ability to be much more specific in how they interact with the body, meaning fewer side effects. But the shocker is that:unlike traditional drugs, biologics aren't vulnerable to generic competition, because the U.S. Food & Drug Administration is still mulling over how to regulate them. So instead of getting exclusive marketing rights for a decade as is the case with many other drugs, manufacturers of biologics get protection indefinitely—or at least until the FDA develops regulations.Importantly, this doesn't mean that they aren't licensed and tested, but that the production and testing of them is significantly different because of their biological starting point. As the FDA states:
Because, in many cases, there is limited ability to identify the identity of the clinically active component(s) of a complex biological product, such products are often defined by their manufacturing processes. Changes in the manufacturing process, equipment or facilities could result in changes in the biological product itself and sometimes require additional clinical studies to demonstrate the product's safety, identity, purity and potency. Traditional drug products usually consist of pure chemical substances that are easily analyzed after manufacture. Since there is a significant difference in how biological products are made, the production is monitored by the agency from the early stages to make sure the final product turns out as expected.
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