Archive for July, 2011



Negative Headlines, Scientific Vulnerability and the Future of Genetic Tests

July 19th, 2011
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Though the life sciences industry is making great progress with genetic tests and targeted therapies, a recent article in the New York Times (“How Bright Promise in Cancer Testing Fell Apart”) exposes disturbing and cautionary insights into the application of this technology. The article revealed that research on the application of complex genetic tests to match cancer patients to the best available therapy may not be as promising as it seems.
 
The article describes a situation that emerged just over a year ago that raised serious doubts about a test developed by researchers at Duke University. The test used gene expression signatures to characterize tumors and to identify those most likely to respond to different drugs.
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What FDA’s Proposed Drug Testing Guidelines May Mean for You

July 15th, 2011
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This week, the FDA issued draft guidance for in vitro companion diagnostics. After a day or so of reflecting about it, here’s what I think it may mean for you:
 
Overall, while the guidance itself may not be BIG news, it does seem to make good sense for business and to offer life science companies some flexibility. Whether you are a therapeutics company or a diagnostics company, you should see new opportunities as a result.
 
Following are the key points I took away from my review of the guidance:

     

  • The FDA acknowledges that not all co-development of diagnostic tests and therapeutic drugs can occur simultaneously. Thus, there is room for you to secure approval of a drug before the test is available and also to seek to modify the drug’s label as new diagnostics information emerges. There is also room for you to potentially market an as yet uncleared or unapproved test, if the marketing of the test is critical in the context of a drug. Read the rest of this entry »

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In Battle Against HAIs, Innovative Biotechs Play Key Role

July 12th, 2011
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HAIs (hospital acquired infections) are the cause of 1.7 million infections and 100,000 deaths per year in U.S. hospitals. While the majority of these infections can be prevented through basic practices such as good hand-washing and aseptic techniques, the unfortunate reality is that many hospitals and administrators are reluctant to disclose or report negative information concerning HAIs, hindering the ability of all healthcare facilities to work together on a national level to analyze the problem and develop an effective preventative strategy.
 
This problem was addressed by Don Wright, M.D., M.P.H., Deputy Assistant Secretary for Healthcare Quality at the U.S. Dept. of Health and Human Services, in a compelling keynote at the Cleveland Clinical Health Care Quality Innovation Summit. This summit, and Dr. Wright’s speech, left us feeling that while there may be difficult mountains to climb, there are always paths to get to the top when we have the knowledge that we’re not alone in our journey.
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Google’s Blind Date with Consumer Health

July 6th, 2011
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Even great athletes – like Rafael Nadal at this year’s Wimbledon Championships – suffer setbacks and losses at times. Thus, we shouldn’t be too hard on Google for the recent downfall of Google Health, although we may analyze it and look for lessons learned just as Rafael surely does after a losing match.
 
The Google Health downfall carries with it a long chain of assumptions: everything ranging from design clumsiness to the search engine giant’s inability to bring the medical community into its fold. MIT’s own Technology Review chalked up the failure to the nation’s broken medical system and a recent article in Mobihealthnews (“10 Reasons Why Google Failed”) outlined it so clearly that you could use it for study in a Business 101 class.
 
Putting all other missteps aside, I believe many companies veer off track in the earliest phases of product planning. Large corporations, by virtue of pure muscle, sometimes are further burdened when they think they can create a need where one simply doesn’t exist. In this case, Google miscalculated whose problem it was they were actually trying to address.
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