Archive for August, 2011

Yes, “Too Big” Can be a Problem in Device & Diagnostics Companies, Too

August 29th, 2011
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This morning, Luke Timmerman of Xconomy wrote about “The Fall of Pfizer: How Big is Too Big for Pharma Innovation?” Acknowledging that while big companies such as Apple and Google are known for innovation – in contrast to some of the large pharmaceutical companies, Luke asked, “Is there something about life sciences that requires it to stay small if it wants to innovate?” He goes on to write about a Fortune article that captured some of Pfizer’s recent woes, which appear to be based upon micro-management, indecisiveness, second-guessing, office politics, and more.
From our vantage points as life science consultants with operational experience in big and small device companies and who spend considerable time now working with life sciences start-ups as well as with large companies, it is clear that “too big” can also be a major issue for diagnostic and device organizations.
Following are a few thoughts for our friends and clients to bear in mind:

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On Patenting Genes and Their Correlations: It’s a Chicken-Egg Problem

August 26th, 2011
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Last month, my colleague Shane Climie wrote a post inspired by an article in the New York Times (“How Bright Promise in Cancer Testing Fell Apart”), which exposed disturbing and cautionary insights into the application of genetic testing technology. Today, I’m responding to a recent New York Times article in which reporter Andrew Pollack wrote of challenges facing Myriad Genetics in spite of the company having received a victory when a federal appeals court upheld the company’s patents on two human genes ­– and the validity of gene patents.
It’s worth checking out Andy’s article for more context, but here are my two cents on some of the issues covered:


  • My hunch is that eventually courts will rule (and in so doing give clear guidance) that while products of nature cannot be patented, companies likely will be able to continue to patent the knowledge that a gene or other physiological marker (all of which are “products of nature”) correlates to a particular condition, disease, and/or drug response. This is a key point of clarity that is needed in order for the field of “personalized medicine” to reach its full potential. Read the rest of this entry »

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