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Bert Spilker's Pharma Principles of The Week

Friday, February 23, 2007 04:17 PM

Posted by: Bert Spilker

  • Internal benchmarking tracks activities and is extremely important to measure progress toward goals. External benchmarking is generally a case of chasing the other guy’s tail. If the external data can be validated then those data will also have value.
  • Good ethics and high scientific and medical standards can and should be used as a means to beat the competition.  Regulatory agencies may raise the bar for others developing similar products, if you have raised it yourself.
  • Using minimally acceptable criteria for continuing with a product’s development facilitates the best business decisions and helps to avoids games being played on prematurely terminating or prolonging a dying or even a dead project.

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).

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